Using biomarkers to guide the discharge of heart failure patients from the hospital

BiomarkeR cAndidates to Guide Discharge of Patients Admitted to Hospital With heARt Failure

This study is testing if using specific blood tests can help doctors decide when it's safe to send heart failure patients home from the hospital, compared to standard care.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 750 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Ottawa Heart Institute Research Corporation (other)
• Locations: 1 site (Ottawa, Ontario)
• Trial ID: NCT03103932 on ClinicalTrials.gov

What this trial studies

This multi-centre, single blind, randomized study aims to improve the discharge process for patients admitted with acute decompensated heart failure. Participants will be randomized to either a biomarker guided discharge algorithm or usual care, with NTproBNP and other biomarkers measured shortly after admission. Based on these biomarker levels, patients will be stratified into lower and medium-higher risk pathways, with tailored discharge planning and follow-up care. The study will monitor participants for 30 days post-discharge and conduct follow-up evaluations at 3 and 6 months.

Who should consider this trial

Good fit: Ideal candidates are patients admitted to the hospital with a primary diagnosis of acute decompensated heart failure.

Not a fit: Patients with end-stage organ failure, those requiring intubation, or with a life expectancy of less than 6 months may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more timely and appropriate discharges for heart failure patients, potentially reducing readmission rates and improving overall patient outcomes.

How similar studies have performed: Other studies have shown promise in using biomarkers for managing heart failure, suggesting that this approach may be beneficial.

Eligibility criteria

Inclusion Criteria:

* Patients admitted to hospital with a primary diagnosis of acute decompensated heart failure, compatible with the modified Framingham criteria

Exclusion Criteria:

* Patient unable to provide blood samples or cannot participate in follow-up
* Patient with end stage organ failure

  * Kidney: creatinine \>350 μmol/L or Estimated GFR ≤15 ml/min
  * Liver dysfunction: liver function test \>2.5 times normal
  * Lungs: pulmonary FEV1\<50% predicted
* Patient requiring intubation
* Patient with an admission NTproBNP measurement of \>30,000 pg/ml
* Patient listed for heart transplant, or admitted specifically for transplant workup
* Patient in cardiogenic shock
* Patient with life expectancy of less than 6 months, or has major co-morbidities such as new stroke, cancer, pneumonia, or other serious life threatening illness
* Patient with conditions that will make it difficult to discharge from hospital such as a fall or waiting for a long term care bed
* Any other significant disease or disorder which, in the opinion of the Investigator, may either put the patient at risk because of participation in the trial, or may bias the result of the trial, or the patient's ability to participate in the trial
* Patient who has participated in another research trial involving an investigational product in the past 30 days

Where this trial is running

Ottawa, Ontario

• University of Ottawa Heart Institute — Ottawa, Ontario, Canada (RECRUITING)

Study contacts

• Principal investigator: Peter Liu, MD — Ottawa Heart Institute Research Corporation
• Study coordinator: Ermina Moga, MD

Conditions: Heart Failure, With Decompensation, biomarkers, heart failure, hospital admission